Objective: To systematically review the efficacy and safety of insulin degludec/insulin aspart(IDegAsp) versus biphasic aspart 30(BIAsp 30) in the treatment of type 2 diabetes mellitus(T2DM). Methods: Databases including PubMed, Embase, The Cochrane Library, Clinical Trials, CNKI, Wanfang and VIP were searched for randomized controlled trials(RCTs), comparing the efficacy and safety of IDegAsp versus BIAsp 30 in the treatment of T2DM from inception to April 10,2021. The Meta-analysis was performed by RevMan 5.4 and Stata 14.0. Results: Seven RCTs with 2 256 participants were included. The Meta-analysis showed that IDegAsp was superior to BIAsp 30 in reducing the level of fasting plasma glucose(FPG)(MD=-1.30, 95%CI-1.50-1.09,P<0.01) and end-point daily average insulin dosage(MD=-0.15, 95%CI -0.19-0.11, P<0.01), however, the difference between IDegAsp and BIAsp 30 in the change of glycosylated hemoglobin(HbA1c) and body weight from baseline was not statistically significant(P>0.05). The incidence of nocturnal hypoglycemic in IDegAsp was significantly lower than that in BIAsp 30(RR=0.61, 95%CI 0.52-0.71,P<0.01),but there was no significant difference between IDegAsp and BIAsp 30 in the incidence of overall severe hypoglycemia and adverse events. Conclusion: Compared with BIAsp 30, IDegAsp can significantly reduce FPG, insulin dosage and the incidence of nocturnal hypoglycemic, which will not increase the weight and the overall risk of adverse events. |
[1] SAEEDI P,PETERSOHN I,SALPEA P,et al.Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045:results from the international diabetes federation diabetes atlas,9(th) edition[J].Diabetes Res Clin Pract,2019,157:107843.
[2] American Diabetes Association.Pharmacologic approaches to glycemic treatment:standards of medical care in diabetes-2020[J].Diabetes Care,2020,43(8):98-110.
[3] ELIZAROVA S,GALSTYAN G R,WOLFFENBUTTEL B H.Role of premixed insulin analogues in the treatment of patients with type 2 diabetes mellitus:a narrative review[J].J Diabetes,2014,6(2):100-110.
[4] MCCRIMMON R J,AL SIFRI S,EMRAL R,et al.Advancing therapy with iGlarLixi versus premix BIAsp 30 in basal insulin-treated type 2 diabetes:design and baseline characteristics of the SoliMix randomized controlled trial[J].Diabetes Obes Metab,2021,23(6):1221-1231.
[5] GLASTRAS S J,COHEN N,DOVER T,et al.The clinical role of insulin degludec/insulin aspart in type 2 diabetes:an empirical perspective from experience in Australia[J].J Clin Med,2020,9(4):1091-1107.
[6] HIGGINS J P,ALTMAN D G,GØTZSCHE P C,et al.The cochrane collaboration's tool for assessing risk of bias in randomised trials[J].BMJ,2011,343:5928-5936.
[7] FRANEK E,HALUZÍK M,CANECKI VARŽIĆ S,et al.Twice-daily insulin degludec/insulin aspart provides superior fasting plasma glucose control and a reduced rate of hypoglycaemia compared with biphasic insulin aspart 30 in insulin-naïve adults with type 2 diabetes[J].Diabet Med,2016,33(4):497-505.
[8] FULCHER G R,CHRISTIANSEN J S,BANTWAL G,et al.Comparison of insulin degludec/insulin aspart and biphasic insulin aspart 30 in uncontrolled,insulin-treated type 2 diabetes:a phase 3a,randomized,treat-to-target trial[J].Diabetes Care,2014,37(8):2084-2090.
[9] HASSANEIN M,ECHTAY A S,MALEK R,et al.Original paper:efficacy and safety analysis of insulin degludec/insulin aspart compared with biphasic insulin aspart 30:a phase 3,multicentre,international,open-label,randomised,treat-to-target trial in patients with type 2 diabetes fasting during ramadan[J].Diabetes Res Clin Pract, 2018,135:218-226.
[10] KANEKO S,CHOW F,CHOI D S,et al.Insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Asian patients with type 2 diabetes inadequately controlled on basal or pre-/self-mixed insulin: a 26-week,randomised,treat-to-target trial[J].Diabetes Res Clin Pract,2015,107(1):139-147.
[11] NISKANEN L,LEITER L A,FRANEK E,et al.Comparison of a soluble co-formulation of insulin degludec/insulin aspart vs biphasic insulin aspart 30 in type 2 diabetes:a randomised trial[J].Eur J Endocrinol,2012,167(2):287-294.
[12] ONISHI Y,YAMADA K,ZACHO J,et al.Insulin degludec/insulin aspart vs biphasic insulin aspart 30 twice daily in Japanese patients with type 2 diabetes:a randomized controlled trial[J].J Diabetes Investig,2017,8(2):210-217.
[13] YANG W,MA J,HONG T,et al.Efficacy and safety of insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Chinese adults with type 2 diabetes:a phase Ⅲ,open-label,2∶1 randomized,treat-to-target trial[J].Diabetes Obes Metab,2019,21(7):1652-1660.
[14] HAAHR H,FITA E G,HEISE T.A review of insulin degludec/insulin aspart:pharmacokinetic and pharmacodynamic properties and their implications in clinical use[J].Clin Pharmacokinet,2017,56(4):339-354.
[15] KALRA S.Insulin degludec aspart:the first co-formulation of insulin analogues[J].Diabetes Ther,2014,5(1):65-72.
[16] ATKIN S,JAVED Z,FULCHER G.Insulin degludec and insulin aspart:novel insulins for the management of diabetes mellitus[J].Ther Adv Chronic Dis,2015,6(6):375-388.
[17] MEHTA R,CHEN R,HIROSE T,et al.Practical use of insulin degludec/insulin aspart in a multinational setting:beyond the guidelines[J].Diabetes Obes Metab,2020,22(11):1961-1975.
[18] DEMIR T,TURAN S,UNLUHIZARCI K,et al.Use of insulin degludec/insulin aspart in the management of diabetes mellitus:expert panel recommendations on appropriate practice patterns[J].Front Endocrinol(Lausanne),2021,12:616514.
[19] HALUZÍK M,FULCHER G,PIEBER T R,et al.The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia,independent of baseline glycated haemoglobin levels,disease duration or body mass index:a pooled meta-analysis of phase Ⅲ studies in patients with type 2 diabetes[J].Diabetes Obes Metab,2018,20(7):1585-1592.
[20] 陶立波,王芳旭.医保准入后德谷门冬双胰岛素对比甘精胰岛素治疗口服降糖药控制不佳的中国2型糖尿病患者的成本-效果[J].药品评价,2021,18(4):193-196. |